Download A once-daily prenatal vitamin supplement, including key omega

A once-daily prenatal vitamin supplement,
including key omega-3 fatty acids (DHA and EPA)
and 1 mg folic acid
PRECAUTIONS
Rx Only
Geriatric Use: Clinical studies on this product have not been
performed to determine whether elderly subjects respond
differently from younger subjects. In general, dose selection
for an elderly patient should be cautious, usually starting at the
low end of the dosing range, reflecting the greater frequency
of decreased hepatic, renal, or cardiac function, and of
concomitant disease or other drug therapy.
DESCRIPTION: PrimaCare® ONE is a prescription prenatal/
postnatal multivitamin/mineral capsule with omega-3 fatty acids.
Each purple soft gelatin capsule for oral administration contains:
Essential Fatty Acids:
Omega-3 Fatty Acids . . . . . . . .
Docosahexaenoic Acid (DHA)
Eicosapentaenoic Acid (EPA) .
α-Linolenic Acid (ALA) . . . . . .
Linoleic Acid . . . . . . . . . . . . . .
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.330 mg
.260 mg
. .40 mg
. .30 mg
. .30 mg
Vitamins:
Vitamin C (as Ester-C ®*) . . . . . . . . . . . . . . . . . . 25 mg
Vitamin D3 (cholecalciferol) . . . . . . . . . . . . . . . .170 IU
Vitamin E (dl-alpha-tocopheryl acetate) . . . . . . . . .30 IU
Folic Acid, USP . . . . . . . . . . . . . . . . . . . . . . . . . .1 mg
Vitamin B6 (pyridoxine hydrochloride) . . . . . . . . . 25 mg
Minerals:
Calcium . . . . . . . . . . . . . . . . . . . . . . . . . . . . .150 mg
Iron
Carbonyl iron (elemental iron) . . . . . . . . . . . . .20 mg
Sumalate™ † (elemental iron) . . . . . . . . . . . . . . .7 mg
*Ester-C ® is a patented pharmaceutical grade material
consisting of calcium ascorbate and calcium threonate.
Ester-C ® is a licensed trademark of The Ester C Company.
†Sumalate™ (ferrous asparto glycinate) is a trademark of
Albion International, Inc., Clearfield, Utah. U.S. Patent pending.
Inactive Ingredients: D&C Red No. 33, ethylvanillin,
FD&C Blue No. 1, gelatin, glycerine, hydrogenated vegetable
oil, lecithin, malic acid, methylparaben, propylparaben,
silicon dioxide, soybean oil, succinic acid, titanium dioxide,
vegetable shortening, and yellow beeswax.
INDICATIONS: PrimaCare® ONE is indicated to provide
vitamin/mineral and omega-3 fatty acid supplementation
throughout pregnancy, during the postnatal period for both
lactating and non-lactating mothers, and throughout the
childbearing years. It is also useful for improving nutritional
status prior to conception.
CONTRAINDICATIONS: This product is contraindicated
in patients with a known hypersensitivity to any of the
ingredients.
WARNINGS: Folic acid alone is improper therapy in the
treatment of pernicious anemia and other megaloblastic
anemias where vitamin B12 is deficient. Folic acid in doses
above 1.0 mg daily may obscure pernicious anemia,
in that hematologic remission can occur while neurological
manifestations remain progressive.
WARNING: Accidental overdose of ironcontaining products is a leading cause of
fatal poisoning in children under 6. Keep this
product out of reach of children. In case of
accidental overdose, call a doctor or poison
control center immediately.
Pediatric Use: Safety and effectiveness in pediatric patients
have not been established.
ADVERSE REACTIONS: Allergic sensitization has been
reported following both oral and parenteral administration
of folic acid.
DOSAGE AND ADMINISTRATION: Usual dosage is one
capsule daily, or as prescribed by a physician.
HOW SUPPLIED: PrimaCare® ONE prenatal/postnatal
multivitamin/mineral capsules are purple soft gelatin capsules,
imprinted “Ther-Rx 200” in white ink, packaged in bottles of
30 capsules (NDC 64011-200-19).
Store at controlled room temperature 15°—30° C (59°—86° F).
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF
CHILDREN.
P5516 03/07
Manufactured by Accucaps Industries Limited
Windsor, Ontario, Canada
Marketed by Ther-Rx Corporation
St. Louis, MO 63044
U.S. Patent Nos.: 4,822,816; 5,070,085; 5,516,925;
6,197,329; 6,258,846; 6,569,857; 6,576,666;
6,716,814; 7,112,609.
Other U.S. Patents pending.